The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Medasil Airway (Guedel type), Code 38/2 size 2, manufactured by Medasil Surgical. The affected product identifiers are lot WH61, consignments 355 and 363, expiry 2019/03.
The problem relates to a single device returned to the manufacturer by a user, in which the distal end of the airway was completely blocked. This fault represents a potential serious hazard to patient safety (i.e. suffocation) if the fault is not identified before use in patients.
The manufacturer is performing an immediate recall of the affected lot of airway products.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-7-to-11-december-2015
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 December 2015